Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial

Rigshospitalet

Status: Completed

Conditions: Adverse Event; Cancer, Breast; Chemotherapeutic Toxicity; Patient Outcomes Assessments

Treatments: Other: Completion of PRO-CTCAE items before consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT02996201

R113-A7084-14-S34

Details and patient eligibility

About

The aim of this study is to determine whether the use of breast cancer patients' own electronic reporting of side effects to chemotherapy in a treatment setting has an impact on the handling of side effects and on the number of hospitalizations, febrile neutropenia and dose adjustments. We are using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side effects.

Enrollment: 700 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Gender •Female: only female participants are being studied

Minimum age

•18 years

Maximum age •N/A

Accepts Healthy Volunteers

•No

Eligibility Criteria

Inclusion criteria

• Breast cancer patients starting adjuvant chemotherapy in the period November 1, 2015 - September 1, 2016 in Danish oncology clinics

Exclusion Criteria:

• More than six scheduled cycles of chemotherapy
• Not able to read and understand Danish language

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Electronic reporting of PRO-CTCAE items

Experimental group

Description:

Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy

Treatment:

Other: Completion of PRO-CTCAE items before consultation

Standard practice

No Intervention group